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Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors

NCT06711978•Pusan National University Yangsan Hospital

View on ClinicalTrials.gov

Summary

To conduct a two-arm, parallel, prospective, randomized controlled, open-label trial to compare the efficacy of the novel drug mirogabalin with the conventional treatment duloxetine in reducing pain associated with chemotherapy-induced peripheral neuropathy (CIPN). There will be a difference in pain reduction after 4 weeks of treatment between the mirogabalin group and the duloxetine group in patients with chemotherapy-induced peripheral neuropathy (CIPN). Participants will: * Take drug duloxetine or a mirogabalin every day for 4 weeks. * Visit the clinic once every 2 weeks for checkups and tests

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Cancer survivors aged 19 years or older.
•Peripheral, symmetrical pain in both feet occurring within 12 weeks of initiating chemotherapy with taxane or platinum agents (or their combination).
•Patients experiencing at least grade 2 peripheral neuropathy as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with an average pain intensity of 4 or higher on the Numerical Rating Scale (NRS) during the past week, following the completion of chemotherapy.
•Concurrent use of selected analgesics (acetaminophen, nonsteroidal anti-inflammatory drugs \[NSAIDs\]) is permitted if the following conditions are met:
•1. No new analgesics are introduced.
•2. Current analgesics are not discontinued.
•3. The total weekly 24-hour dose of analgesics does not vary by more than 10% during the 2 weeks prior to enrollment.
•Ongoing treatment for peripheral neuropathy or neuropathic pain must be discontinued at least 7 days before randomization

Exclusion Criteria

•Patients with a prior diagnosis of peripheral neuropathy due to diabetes, trauma, alcohol abuse, compression, or other causes, or those with a previously diagnosed central nervous system disorder. (Patients with pre-existing diabetes or thyroid disease who had no symptoms of peripheral neuropathy, such as numbness or tingling in the hands or feet, before chemotherapy may be included.)
•Patients with significant psychiatric disorders, such as severe depression, bipolar disorder, or suicidal ideation.
•Pregnant or breastfeeding patients.
•Patients with a history of prior treatment with other neurotoxic chemotherapeutic agents.
•Patients with renal impairment (creatinine clearance \< 30 mL/min) or hepatic dysfunction.
•Patients with planned surgical procedures within 4 weeks of enrollment.

Locations (1)

Yangsan Pusan National University Hospital

Mulgeum, South Korea

Key Dates

Start Date

December 1, 2024

Primary Completion Date

May 31, 2025

Completion Date

June 30, 2025

Last Updated

December 2, 2024

Enrollment

ESTIMATED participants

Conditions

CIPNCIPN - Chemotherapy-Induced Peripheral NeuropathyCIPN in Adjuvant Breast Cancer PatientsDuloxetineMirogabalin

Interventions

Mirogabalin

DRUG

Duloxetine

DRUG

Contacts

Seung-mi Yeo

CONTACT

010-3171-9583 seungmi7@gmail.com

Use of PEA and Scutellaria in Synergy With Therapeutic Exercise in Chemotherapy-induced Peripheral Neuropathy (CIPN): a Clinical Trial

NCT07352514

Chemotherapy-induced Peripheral Neuropathy (CIPN)Neuropathic Pain

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RECRUITINGNA

Cryocompression for CIPN

NCT07064798

Chemotherapy-induced Peripheral NeuropathyTaxane-Induced Peripheral Neuropathy+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors

Inclusion Criteria

Exclusion Criteria

Use of PEA and Scutellaria in Synergy With Therapeutic Exercise in Chemotherapy-induced Peripheral Neuropathy (CIPN): a Clinical Trial

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